Recall Z-0048-2022 ยท NCX System, Hypothermia, Intravenous, Cooling
ZOLL Circulation, Inc.
Zoll REF: 8700-0783-01 (IC-4593), QUATTRO Intravascular Heat Exchange Catheter Kit Custom Luer Applause Heparin, Sterile EO, Rx Only, UDI: (01)00849111075282
| Date | Aug 6, 2021 |
| Status | Terminated |
| Reason | Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing |
| Root cause | Labeling design |
| Action | Between the dates of August 27, 2021 and September 3, 2021, ZOLL, issued an "Urgent Medical Device Recall (Correction)" Notification to all affected US consignees via UPS. In addition to informing consignees about the labeling correction, Zoll asked consignees to take the following actions: 1. If you have any questions, please contact Doug Lam (Director of Quality and Compliance) or Sam Nanavati (VP of Quality and Regulatory Affairs) at IVTM_Recall@zoll.com. 2 Provide this notice (letter) to all those who need to be aware within your organization or to any organization where the affected |
| Quantity | 20,475 units |
| Distribution | Worldwide distribution - US Nationwide distribution in the states of AL, AZ, CA, CO, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX, VA, WA, WI, WV and the countries Australia, CANADA, CHINA, GERMANY, HUNGARY, PORTUGAL, SINGAPORE, T |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K150046 | Start-Up Kit (SUK), Cool Line Intravascular Heat Exchange Catheter, ICY Intravascular Heat Exchange Catheter, Quattro In Zoll Circulation, Inc., Oct 30, 2015 |